Gemcitabine and Docetaxel With Radiation in Adults With Soft Tissue Sarcoma of the Extremities

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this Phase 1 research study is to obtain data or information on the safety and effectiveness of the combination of gemcitabine, docetaxel with radiation.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel; Gemcitabine

Criteria

Inclusion Criteria:

• Patients must have a histologically or cytologically confirmed Grade II or III soft tissue sarcoma that is considered to be resectable and are candidates for pre-op radiation.

• Age greater than or equal to 18 years. No children will be enrolled on this protocol.

• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.

• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or double-barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Patients taking concurrent hormonal therapy, biologic or other chemotherapy are excluded except women on hormonal contraceptives.

• Patients taking an investigational agent are excluded.

• Pregnant and nursing women are excluded.

• Patients who require amputation for local control.

• Patients who underwent unplanned excision or other previous surgery involving the affected extremity.

• Patients with sarcoma subtypes for which established chemotherapeutic regimens exist.

• History of radiation to the limb.